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A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.


This multicenter randomized phase II study will enroll approximately 150 patients with
metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with
weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy
and safety data will be collected. The investigator will assess response to treatment every
8 weeks based on the imaging.

Following permanent treatment cessation, patients will be followed-up for survival.


Inclusion Criteria:



- Signed written informed consent

- Male or female ≥ 18 years of age

- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- Metastatic colorectal carcinoma not suitable for curative-intent resection-
Availability of tumor sample (or able and willing to provide tumor sample) for EGFR
assessment

- Presence of at least one lesion measurable unidimensionally by CT scan or MRI.
(Target lesion(s) must not lie within an irradiated area)

- Karnofsky performance status of > 80 at study entry

- Leucocytes ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L,
and hemoglobin ≥ 9 g/dL.

- Bilirubin ≥ 1.5 x ULN

- ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present)

- Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

- Brain metastasis (known or suspected)

- Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed
if the chemotherapy treatment free interval is > 6 months.

- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study
entry

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol

- Any investigational agent(s) within 4 weeks prior to entry

- Previous exposure to EGFR-pathway targeting therapy

- Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 12 months

- Acute or subacute intestinal occlusion or history of inflammatory bowel disease

- Pre-existing neuropathy > grade 1. In case of prior oxaliplatin containing adjuvant
chemotherapy: pre-existing neuropathy ≥ 1.

- Known grade 3 or 4 allergic reaction to any of the components of the treatment.

- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ
of the cervix. (Patients with a previous malignancy but without evidence of disease
for ≥ 5 years will be allowed to enter the trial)

- Pregnancy or lactation

- Inadequate contraception (male or female patients) if of childbearing or
procreational potential

- Known drug abuse/ alcohol abuse

- Legal incapacity or limited legal capacity

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria

Outcome Description:

Objective response (partial or complete) will be assessed using RECIST criteria. The objective response rate (defined as the rate of subjects with complete response (CR) or partial response (PR)) will be estimated and associated exact two-sided 95% confidence limit (Clopper-Pearson) will be calculated. In addition to the estimates within each treatment group odds ratios and associated 95% CI will be calculated using the Cochran Mantel-Haenszel procedure.

Outcome Time Frame:

The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)

Safety Issue:

Yes

Principal Investigator

Tudor Ciuleanu, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institutul Oncologic of Cluj

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

CECOG /CORE 1.2.002

NCT ID:

NCT00479752

Start Date:

January 2008

Completion Date:

November 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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